MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 60/9 SC1 MECA

Model Number MMT-397A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2022, it was reported that the patient felt shaky, sweaty, and thirsty due to high blood glucose levels.Reportedly, her reservoir leaked.The infusion set was changed on (b)(6) 2022.The recent high blood glucose event began on (b)(6) 2022 and on the same day she was admitted to the hospital.Moreover, her blood glucose level was 417 mg/dl, had high ketones and she experienced diabetic ketoacidosis.During hospitalization she was administered insulin drip intravenously as corrective treatment.Further, she was released after three days.Currently, her blood glucose level was 417 mg/dl.No further information available.

Event Description

On 31-mar-2022 an: follow up information was submitted to update the unique identifier (udi) number and awareness date.Unomedical reference number (b)(4).Event occurred in the united states.On 28-jan-2022, it was reported that the patient felt shaky, sweaty, and thirsty due to high blood glucose levels.Reportedly, her reservoir leaked.The infusion set was changed on (b)(4) 2022.The recent high blood glucose event began on (b)(4) 2022 and on the same day she was admitted to the hospital.Moreover, her blood glucose level was 417 mg/dl, had high ketones and she experienced diabetic ketoacidosis.During hospitalization she was administered insulin drip intravenously as corrective treatment.Further, she was released after three days.Currently, her blood glucose level was 417 mg/dl.No further information available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 60/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13448360
• MDR Text Key: 285040251
• Report Number: 3003442380-2022-00256
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017559
• UDI-Public: 5705244017559
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MMT-397A
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Patient Sequence Number: 1